Prostate Cancer Treatment Protocols 

Prostate Cancer Treatment Protocols 

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Treatment protocols for prostate cancer are provided below, including general treatment recommendations and those for localized prostate cancer, for recurrent disease, and for advanced or metastatic disease.

See Prostate Cancer: Diagnosis and Staging, a Critical Images slideshow, to help determine the best diagnostic approach for this potentially deadly disease.

Also, see the Advanced Prostate Cancer: Signs of Metastatic Disease slideshow for help identifying the signs of metastatic disease.

Selecting initial treatment requires assessing the risk of the disease spreading or progressing, which is based on evaluating the patient’s life expectancy, comorbidities, biopsy grade (Gleason score), clinical stage, and prostate-specific antigen (PSA) level.

Very low risk of recurrence:

Patients with clinical stage T1c, Gleason score ≤6, PSA </li>

Active surveillance includes periodic PSA testing, digital rectal examination (DRE), and prostate biopsy. The optimal protocol for surveillance is still unknown, [1, 2, 3] but may include PSA as often as every 3 mo or at least every 6 mo, DRE as often as every 6 mo but at least every 12 mo, and repeat biopsy within 18 mo but as often as every 12 mo or if PSA and DRE change [4, 5, 6]

For treatment recommendations for patients with a life expectancy ≥20 y, see initial therapy for Low Risk of Recurrence, below

Low risk of recurrence:

Treatment for patients with clinical stage T1-T2a, Gleason score 2-6, PSA 7</ref>

Treatment for patients with a life expectancy ≥10y includes active surveillance or

Radical prostatectomy (RP) with or without pelvic lymph node dissection (PLND); RP is the standard therapy for localized prostate cancer, involving the removal of the prostate and seminal vesicles with or without pelvic lymph nodes; this may be done using either open or laparoscopic (robotic-assisted) technique [3, 8, 9] or

External beam radiation therapy is a standard therapy for patients with localized disease; 3-dimensional (3D) techniques such as 3D conformal radiation treatment (3D-CRT) offer reduced toxicity and the use of higher doses; second-generation techniques, including intensity-modulated radiation therapy (IMRT), are also required, especially if doses ≥78 Gy are administered [10]

Patients with low-risk cancer are not candidates for pelvic lymph node irradiation or ADT [12]

Intermediate risk of recurrence:

Treatment options for patients with clinical stage T2b-T2c, Gleason score 7 or PSA 10-20 ng/mL, who have a life expectancy or</b>

Radiation therapy (doses of 78-80+ Gy) with 3D-CRT/IMRT with daily IGRT with or without short-term neoadjuvant/concomitant/adjuvant ADT for 4-6 mo with or without brachytherapy (recommended dose rate: 145 Gy for iodine-125 and 125 Gy for palladium-103) [13, 14]

Treatment recommendations for patients with a life expectancy ≥10 y include RP with PLND or

Radiation therapy (doses of 78-80+ Gy) with 3D-CRT/IMRT with daily IGRT with or without short-term neoadjuvant/concomitant/adjuvant ADT for 4-6 mo with or without brachytherapy (recommended dose rate: 145 Gy for iodine-125 and 125 Gy for palladium-103)

Intermediate-risk cancers consider combining brachytherapy (recommended dose rate: 145 Gy for iodine-125 and 125 Gy for palladium-103) with external beam radiation therapy (EBRT)(40-50 Gy) with or without 4-6 mo neoadjuvant/concomitant/adjuvant ADT

Administering ADT before, during, and after radiation prolongs survival [15]

High risk of recurrence:

Clinical stage T3a, Gleason score 8-10, PSA >20 ng/mL

Treatment options include RP plus PLND for selected patients or

Radiation therapy (doses of 78-80+ Gy) with 3D-CRT/IMRT plus long-term neoadjuvant/concomitant/adjuvant ADT for 2-3 y or

Radiation therapy (doses of 78-80+ Gy) with 3D-CRT/IMRT with daily IGRT plus brachytherapy (recommended dose rate: 145 Gy for iodine-125 and 125 Gy for palladium-103) with or without short-term neoadjuvant/concomitant/adjuvant ADT for 4-6 mo or

High-risk cancers may be treated with combination EBRT (40-50 Gy) and brachytherapy with or without 4-6 mo neoadjuvant/concomitant/adjuvant ADT

Other treatments that have been used in the initial management of localized prostate cancer include the following:

Cryotherapy:

Cryotherapy (also known as cryosurgery or cryoablation) involves using transrectal ultrasonographic guidance; percutaneous cryoprobes are placed and used to freeze prostate tissue

This treatment is not preferred as a standard curative treatment option but may be used in select patients with localized prostate cancer or as focal therapy in low-risk patients (experimental) [16]

Can also be considered as salvage therapy after failed radiation therapy [17]

Complications include tissue sloughing, perineal ecchymosis, stricture or contracture, incontinence, impotence, and fistula formation between the urinary and gastrointestinal tracts

High-intensity focused ultrasound [18] :

Particle beam therapy [21] :

See the list below:

Approximately 20-30% of patients treated with intent for cure will have biochemical recurrence, which most commonly manifests as a rising PSA level [22, 23]

Biopsy of the prostatic bed is usually not recommended unless the patient is a candidate for salvage therapy

Monitor PSA, alkaline phosphatase, and calcium every 6 months to determine whether the doubling time is less than 1 year

See the list below:

Defined as a detectable PSA that increases on two subsequent measurements or a PSA that fails to fall to undetectable levels

PSA that fails to fall to undetectable levels after prostatectomy may indicate residual prostate cancer or prostate cancer

Treatment options include salvage radiation therapy, androgen deprivation, and surveillance

Adjuvant radiation therapy may be more beneficial than salvage radiation therapy in men with poor pathologic features [2, 3]

See the list below:

Defined as a rise in PSA of 2 ng/ml or more above the nadir [25, 26, 27]

PSA can bounce up and down after radiation

Treatment options include salvage prostatectomy, ADT, surveillance, high-intensity focused ultrasound (clinical trials), cryotherapy, repeat irradiation

Very high risk:

Clinical stage T3b-T4 treatment options include radiation therapy (doses of 78-80+ Gy) with 3D-CRT/IMRT plus  long-term neoadjuvant/concomitant/adjuvant androgen deprivation therapy (ADT) for 2-3 y or

Radiation therapy (doses of 78-80+ Gy) with 3D-CRT/IMRT with daily IGRT plus brachytherapy with or without short-term neoadjuvant/concomitant/ADT for 4-6 mo or

RP plus PLND for selected patients (those with clinically localized prostate cancer that can be completely excised surgically, life expectancy of at least 10 years, and no serious comorbid conditions that would contraindicate elective surgery) [7]   or

ADT alone, in patients with T3 disease and/or node-positive disease and PSA doubling time less than 10 months

Nonmetastatic castration-resistant prostate cancer can be treated with apalutamide 240 mg (ie, four 60-mg tablets) PO daily; administer with GnRH analog concurrently, unless the patient has had bilateral orchiectomy [28]

Metastatic disease:

Any T, N1: Treatment includes ADT or radiation therapy (doses of 78-80+ Gy) with 3D-CRT/IMRT with IGRT plus long-term neoadjuvant/concomitant/adjuvant ADT for 2-3y

Any T, any N, M1: Treatment includes only ADT for patients with M1

See the list below:

ADT is a preferred initial treatment for symptomatic metastatic prostate cancer because androgenic effects promote the growth and malignant transformation of prostatic tissue [29]

ADTs include luteinizing hormone (LH) receptor agonists (eg, histrelin, leuprolide), gonadotropin-releasing hormone (GnRH) receptor agonists (eg, goserelin, histrelin, leuprolide, triptorelin) and antagonists (eg, degarelix), and complete androgen blockade (CAB)

CAB includes medical castration with an oral antiandrogen (eg, bicalutamide, flutamide, nilutamide) or surgical castration [30]

Patients who do not show an adequate suppression of serum testosterone (</li>

Monotherapy with nonsteroidal antiandrogens is less effective but these agents are associated with fewer hot flashes and fatigue and do not impair libido

If hormone therapy fails, that therapy should be continued into and through the next hormone manipulation

Gonadotropin-releasing hormone agonists:

Therapy with GnRH analogs may induce medical castration by suppressing luteinizing hormone (LH) production

These agonists can potentially cause a transient surge of LH when therapy is initiated before the LH levels fall (flare phenomenon)

GnRH agonists are offered in 1 mo, 3 mo, and once-yearly depots; premedication with antiandrogen is necessary to prevent flare phenomenon

Leuprolide: 7.5 mg intramuscularly (IM) monthly or  22.5 mg IM every 3 mo or  30 mg IM every 4 mo or  45 mg intravenously (IV) every 6 mo or

Histrelin: one 50-mg subcutaneous (SC) implant every 12 mo [31] ; continue therapy until disease progression or

Goserelin: 3.6-mg implant SC monthly or  a 10.8-mg implant [31] SC every 3 mo or

Triptorelin: 3.75 mg IM monthly or  11.25 mg IM every 3 mo or 22.5 mg IM every 6 mo

Gonadotropin-releasing hormone antagonists:

Nonsteroidal antiandrogens for non–castrate-resistant disease:

Antiandrogens bind to androgen receptors and competitively inhibit their interaction with testosterone and dihydrotestosterone

These agents do not decrease LH levels and androgen production

Antiandrogens are usually used in combination with a GnRH agonist, to prevent a disease flare caused by the transient increase in testosterone levels

Flutamide 250 mg orally (PO) TID or

Bicalutamide 50 mg PO daily; patients refractory to other antiandrogen agents may start with 150 mg PO daily or

Nilutamide 300 mg PO daily for 30 days, and then  150 mg PO daily or

Enzalutamide (160 mg PO daily), which was previously indicated only for metastatic castration-resistant prostate cancer in patients who had received docetaxel; it is now approved also for patients who have not received chemotherapy [32]

Chemohormonal therapy for hormone-sensitive metastatic disease

Castrate-resistant metastatic disease

See the list below:

All patients with metastatic disease become resistant to ADT

Radiation may be used for palliation in patients with painful bone metastases or impending spinal cord compression

Surgical intervention may be necessary for weight-bearing bones involved in pathologic fracture

Therapeutic options are limited, and the focus is on improving quality of life using single or multimodal therapies

Docetaxel every 3 wk plus prednisone is the treatment of choice for men with symptomatic castration-recurrent prostate cancer; [38, 39, 40] recommended dose is docetaxel 75 mg/m2 IV on day 1 plus prednisone 5 mg PO BID; repeat cycle every 21 days for up to a total of 10 cycles (premedicate with oral corticosteroids starting 1 day before docetaxel administration to reduce incidence of hypersensitivity reactions and fluid retention)

Abiraterone (Zytiga) is approved for treatment of patients with metastatic CRPC cancer who are either chemotherapy-naive or who have had prior docetaxel therapy; recommended dose is 1000 mg PO once daily plus  prednisone 5 mg PO BID [36, 37, 41, 42] ; in addition, de Bono et al reported that abiraterone prolonged overall survival in patients with metastatic castration-resistant prostate cancer who had received prior chemotherapy. [43]

An ultramicronized abiraterone tablet (Yonsa) was approved in May 2018 for CRPC in combination with methylprednisolone. The ultramicronized formulation may be administered with or without food, whereas, the original tablet formulation (Zytiga) must be administered 1 hour before or 2 hours after meals.

Abiraterone (Yonsa): 500 mg (four 125-mg ultramicronized tablets) PO daily plus methylprednisolone 4 mg PO BID

Cabazitaxel with prednisone can be used for patients who have hormone-refractory metastatic prostate cancer that was previously treated with a docetaxel-containing treatment regimen; cabazitaxel 25 mg/m2 IV every 3 wk; infuse IV over 1 h; use inline filter (0.22 µm) during administration plus  prednisone 10 mg PO daily; reduce cabazitaxel dose to 20 mg/m2 with prolonged or febrile neutropenia or with persistent or severe diarrhea

Treatment recommendations for patients with castration-recurrent prostate cancer and bone metastases

Bisphosphonates are recommended for all men with hormone-refractory prostate cancer and bone metastases [44, 7] Bisphosphonates have been shown to reduce skeleton-related events such as pathologic fracture. Optionss are as follows:

The radiopharmaceutical radium-223 dichloride (Xofigo) is approved for men with castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastatic disease:

50 kBq (1.36 microcurie) per kg IV infused over 1 minute; repeat q 4 wk for six cycles total; dosage calculation must be based on decay correction factor of radium-223 (listed in prescribing information) [45]

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Lu-Yao GL, Albertsen PC, Moore DF, et al. Survival following primary androgen deprivation therapy among men with localized prostate cancer. JAMA. 2008 Jul 9. 300(2):173-81. [Medline]. [Full Text].

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Merrick GS, Butler WM, Wallner KE, Galbreath RW, Adamovich E. Permanent interstitial brachytherapy in younger patients with clinically organ-confined prostate cancer. Urology. 2004 Oct. 64(4):754-9. [Medline].

Lawton CAF, Lin X, Hanks GE, Lepor H, Grignon DJ, Brereton HD, et al. Duration of Androgen Deprivation in Locally Advanced Prostate Cancer: Long-Term Update of NRG Oncology RTOG 9202. Int J Radiat Oncol Biol Phys. 2017 Jun 1. 98 (2):296-303. [Medline].

Babaian RJ, Donnelly B, Bahn D, et al. Best practice statement on cryosurgery for the treatment of localized prostate cancer. J Urol. 2008 Nov. 180(5):1993-2004. [Medline].

Ismail M, Ahmed S, Kastner C, Davies J. Salvage cryotherapy for recurrent prostate cancer after radiation failure: a prospective case series of the first 100 patients. BJU Int. 2007 Oct. 100(4):760-4. [Medline].

Crouzet S, Rouviere O, Martin X, Gelet A. High-intensity focused ultrasound as focal therapy of prostate cancer. Curr Opin Urol. 2014 May. 24 (3):225-30. [Medline].

Nelson R. FDA Approves First HIFU Device for Prostate Tissue Ablation. Medscape Medical News. Available at http://www.medscape.com/viewarticle/853120#vp_2. October 22, 2015; Accessed: September 28, 2017.

Johnson K. New FDA-Approved Prostate ‘Tool’: Will You HIFU?. Medscape Medical News. Available at http://www.medscape.com/viewarticle/863037. May 8, 2016; Accessed: September 28, 2017.

Shioyama Y, Tsuji H, Suefuji H, Sinoto M, Matsunobu A, Toyama S, et al. Particle radiotherapy for prostate cancer. Int J Urol. 2015 Jan. 22 (1):33-9. [Medline]. [Full Text].

Freedland SJ, Moul JW. Prostate specific antigen recurrence after definitive therapy. J Urol. 2007 Jun. 177(6):1985-91. [Medline].

Simmons MN, Stephenson AJ, Klein EA. Natural history of biochemical recurrence after radical prostatectomy: risk assessment for secondary therapy. Eur Urol. 2007 May. 51 (5):1175-84. [Medline].

Amling CL, Bergstralh EJ, Blute ML, Slezak JM, Zincke H. Defining prostate specific antigen progression after radical prostatectomy: what is the most appropriate cut point?. J Urol. 2001 Apr. 165(4):1146-51. [Medline].

Wiegel T, Bottke D, Steiner U, et al. Phase III postoperative adjuvant radiotherapy after radical prostatectomy compared with radical prostatectomy alone in pT3 prostate cancer with postoperative undetectable prostate-specific antigen: ARO 96-02/AUO AP 09/95. J Clin Oncol. 2009 Jun 20. 27(18):2924-30. [Medline].

Van der Kwast TH, Bolla M, Van Poppel H, et al. Identification of patients with prostate cancer who benefit from immediate postoperative radiotherapy: EORTC 22911. J Clin Oncol. 2007 Sep 20. 25(27):4178-86. [Medline].

Roach M 3rd, Hanks G, Thames H Jr, et al. Defining biochemical failure following radiotherapy with or without hormonal therapy in men with clinically localized prostate cancer: recommendations of the RTOG-ASTRO Phoenix Consensus Conference. Int J Radiat Oncol Biol Phys. 2006 Jul 15. 65(4):965-74. [Medline].

Smith MR, Saad F, Chowdhury S, Oudard S, Hadaschik BA, Graff JN, et al. Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer. N Engl J Med. 2018 Feb 8. [Medline]. [Full Text].

Loblaw DA, Virgo KS, Nam R, et al. Initial hormonal management of androgen-sensitive metastatic, recurrent, or progressive prostate cancer: 2006 update of an American Society of Clinical Oncology practice guideline. J Clin Oncol. 2007 Apr 20. 25(12):1596-605. [Medline].

Prostate Cancer Trialists Collaborative Group. Maximum androgen blockade in advanced prostate cancer: an overview of the randomised trials. Prostate Cancer Trialists’ Collaborative Group. Lancet. 2000 Apr 29. 355(9214):1491-8. [Medline].

Terk MD, Stock RG, Stone NN. Identification of patients at increased risk for prolonged urinary retention following radioactive seed implantation of the prostate. J Urol. 1998 Oct. 160(4):1379-82. [Medline].

Beer TM, et al; PREVAIL Investigators. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014 Jul 31. 371 (5):424-33. [Medline]. [Full Text].

Sweeney CJ, Chen YH, Carducci M, Liu G, Jarrard DF, Eisenberger M, et al. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer. N Engl J Med. 2015 Aug 20. 373 (8):737-46. [Medline]. [Full Text].

Kantoff PW, Higano CS, Shore ND, et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010 Jul 29. 363(5):411-22. [Medline].

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Petrylak DP, Tangen CM, Hussain MH, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004 Oct 7. 351(15):1513-20. [Medline].

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James ND, Sydes MR, Clarke NW, Mason MD, Dearnaley DP, et al. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial. Lancet. 2016 Mar 19. 387 (10024):1163-77. [Medline]. [Full Text].

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Winston W Tan, MD, FACP Associate Professor of Medicine, Mayo Medical School; Consultant and Person-in-Charge of Genitourinary Oncology-Medical Oncology, Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic Jacksonville; Vice Chairman of Education, Division of Hematology/Oncology, Mayo Clinic Florida

Winston W Tan, MD, FACP is a member of the following medical societies: American College of Physicians, American Society of Clinical Oncology, American Society of Hematology, Philippine Medical Association, Texas Medical Association

Disclosure: Nothing to disclose.

Mary L Windle, PharmD Adjunct Associate Professor, University of Nebraska Medical Center College of Pharmacy; Editor-in-Chief, Medscape Drug Reference

Disclosure: Nothing to disclose.

Christopher D Braden, DO Hematologist/Oncologist, Chancellor Center for Oncology at Deaconess Hospital; Medical Director, Deaconess Hospital Outpatient Infusion Centers; Chairman, Deaconess Hospital Cancer Committee

Christopher D Braden, DO is a member of the following medical societies: American Society of Clinical Oncology, American Society of Hematology

Disclosure: Nothing to disclose.

E Jason Abel, MD Associate Professor of Urologic Oncology, Department of Urology, Associate Professor of Radiology (Affiliate Appointment), Department of Radiology, University of Wisconsin School of Medicine and Public Health; Attending Urologist, William S Middleton Memorial Veterans Hospital

E Jason Abel, MD is a member of the following medical societies: American Medical Association, American Society of Clinical Oncology, American Urological Association, Harris County Medical Society, Kidney Cancer Association, Society for Basic Urologic Research, Society of Urologic Oncology, Texas Medical Association

Disclosure: Nothing to disclose.

Reza Ghavamian, MD Professor of Clinical Urology, Albert Einstein College of Medicine; Director of Urologic Oncology, Director of Minimally Invasive and Robotic Urologic Surgery, Montefiore Medical Center

Reza Ghavamian, MD is a member of the following medical societies: American Urological Association, Society of Urologic Oncology

Disclosure: Nothing to disclose.

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